Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children

Obesity Clinical Trial

Official title:

Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703347
• Other study ID #: 22-019805
• Secondary ID: 1R01HD108243-01
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: Children's Hospital of Philadelphia
• Contact: Jonathan Mitchell, PhD
• Phone: 2674261473
• Email: mitchellj2[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention.

Description:

Insufficient sleep duration is highly prevalent in childhood and is associated with incident obesity, especially among middle school-aged children. Investigators therefore need to identify strategies to increase sleep duration among children for obesity prevention. The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention. This is a single-site study being conducted at the Children's Hospital of Philadelphia (CHOP). Investigators will randomize 325 children, aged 8-12y, with a body mass index (BMI) between the 50th-95th percentile, and who sleep <8.5 hours per night. Clinical measurements will be acquired at CHOP and sleep will be measured in the home setting. The Way to Health mobile platform will facilitate remote communication and data collection. A validated multi-channel sleep tracker will estimate sleep for 12-months (2-week run-in; 6-month intervention; ≈5.5-month follow-up). A randomized 24 factorial design will assess four components: sleep goal (fixed or modifiable), digital guidance (active or active with virtual study visit), parent incentive (inactive or active), and personalized feedback (inactive or active). The optimal component settings will have to meet the following criteria: increase average baseline sleep duration by ≥30 minutes for ≥75% of intervention weeks and for ≥50% of follow-up weeks. Fat mass will be measured at baseline, 6-, and 12-months using dual energy X-ray absorptiometry (DXA). Total energy intake and the timing and composition of meals will be measured using 24-hour dietary recalls at baseline, 6-, and 12-months. Sociodemographic data will be measured using self-report approaches (e.g., sex, race/ethnicity) and home addresses will be geocoded for geo-spatial analyses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Aged 8-12 years olds.

2. Insufficient sleep duration (<8.5 hours per night).

3. Body mass index (BMI) between the 50th and 95th percentile for age and sex.

4. One child per family.

Exclusion Criteria:

1. Diagnosed with a chronic disease.

2. Diagnosed with a behavioral health problem.

3. Diagnosed with a condition that can impact sleep or growth.

4. Diagnosed with a condition affecting physical growth and maturation or dietary intake.

5. Children with a history of cancer, kidney, GI, musculoskeletal, or sleep disorders.

6. Children who will transition to high-school during the study.

7. Children using steroids/hormones.

8. Children regularly taking medications

Related Conditions & MeSH terms

• Obesity
• Sleep Deprivation

Intervention

Behavioral:
• Fixed sleep goal
Investigators will determine if a fixed guideline-based goal (=9 hours per night) is more efficacious for increasing sleep duration.
• Personalized sleep goal
Investigators will determine if a personalized goal (=9 hours per night, but can be lowered to a personalized level, capped at +30 minutes per night above baseline) is more efficacious for increasing sleep duration.
• Digital sleep health messaging without virtual study visit
All participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. This group will NOT have virtual psychological visits.
• Digital sleep health messaging with virtual study visit
All participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. The participants will be randomized to additionally receive virtual study visits where doctoral-level psychology trainees will be trained to implement evidence-based behavioral sleep health guidance.
• Inactive Parent-Directed Loss-Framed Incentive
No parental incentive
• Active Parent-Directed Loss-Framed Incentive
Parents will receive a financial incentive when their child achieves their sleep goal. The incentive will be loss-framed; parents will receive an endowment of $10 at the start of each intervention week, in a virtual bank account; Investigators will deduct $2 each weeknight the sleep duration goal is not met; the funds remaining in the virtual account will be dispensed each Sunday. The weekly endowment-payment approach allows for fresh starts each week. The incentive will be directed at parents as a method to enhance engagement. Investigators will ask parents at baseline and at the end of each month to rate their perceived support in helping their child to meet their sleep duration goal.
• Inactive Supportive Feedback
No supportive feedback
• Active Supportive Feedback
Participants will receive a weekly performance summary message each Sunday during the intervention period, with supportive feedback included to motivate children to maintain their good performance in the week ahead, or to try and improve upon a weak or moderate performance in the week ahead. Investigators will ask children will complete an online survey each Sunday to measure how motivated they are to achieve their sleep goal in the week ahead.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Mayne SL, Morales KH, Williamson AA, Grant SFA, Fiks AG, Basner M, Dinges DF, Zemel BS, Mitchell JA. Associations of the residential built environment with adolescent sleep outcomes. Sleep. 2021 Jun 11;44(6):zsaa276. doi: 10.1093/sleep/zsaa276. — View Citation

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Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021. — View Citation

Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Ludwick A, Grant SFA, Dinges DF, Zemel BA. Changes in Sleep Duration and Timing During the Middle-to-High School Transition. J Adolesc Health. 2020 Dec;67(6):829-836. doi: 10.1016/j.jadohealth.2020.04.024. Epub 2020 Jun 20. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep duration	The primary outcome for aims 1 and 3 is change in nighttime sleep duration (hours per night) on weeknights measured by a sleep tracker with high sensitivity and moderate specificity for measuring sleep.	baseline to 12 months
Primary	Change in fat mass index Z-score	Aim 2 primary outcome. Total body fat mass will be measured by DXA. Fat mass index (FMI, kg of fat divided by height in meters squared) will be calculated, and age and gender specific FMI Z-scores will be determined using U.S. specific FMI growth charts.	Baseline to 12 months
Secondary	Change in sleep onset	Change in sleep onset (time subject falls asleep). Weeknights and weekends will be measured separately.	Baseline to 12 months
Secondary	Change in sleep offset	Change in sleep offset (time subject wakes up). Weeknights and weekends will be measured separately.	Baseline to 12 months
Secondary	Change in sleep midpoint	Change in sleep midpoint. Weeknights and weekends will be measured separately.	Baseline to 12 months
Secondary	Change in social jetlag	Investigators will calculate "social jetlag" by subtracting the weekend night sleep midpoint from the weeknight sleep midpoint. Social jetlag provides an indication of the discrepancy between internal biological clocks and social requirements and has been linked to cardiometabolic risk.	up to 12 months
Secondary	Change in sleep efficiency	Change in sleep efficiency (percentage of time spent asleep during overnight sleep periods). Weeknights and weekends will be measured separately.	Baseline to 12 months
Secondary	Change in sleep onset latency	Change in sleep onset latency (time to fall asleep). Weeknights and weekends will be measured separately.	Baseline to 12 months
Secondary	Change in wake after sleep onset	Change in wake after sleep onset (time awake during overnight sleep periods). Weeknights and weekends will be measured separately.	Baseline to 12 months
Secondary	Change in sleep disturbance and impairment	Measured using the the Patient-Reported Outcomes Measurement Information System (PROMIS) item bank for pediatric sleep. This validated survey generates a sleep disturbance T-score based on items related to sleep onset, sleep continuity and sleep quality in the past week. The survey also generates a sleep-related impairment T-score based on items related to daytime sleepiness, cognition, affect and behavior, and daytime activities in the past week. Higher T-scores indicates poorer sleep quality. Participants will complete this survey at baseline and at the end of each month during the intervention and follow-up periods.	Baseline to 12 months
Secondary	Change in visceral adipose tissue	Visceral adipose tissue area will be measured by DXA.	Baseline to 12 months
Secondary	Change in Body Mass Index (BMI)	Trained Nutrition Core staff will measure heights and weights of participants. These data will be used to calculate body mass index (kg/m2).	Baseline to 12 months
Secondary	Change in waist circumference	Investigators will measure waist circumferences at baseline, 6-months, and 12-months.	Baseline to 12 months